Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-24 @ 5:05 PM
NCT ID:
NCT01595750
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent
* 55-75 years of age
* Current and former smokers \>20 cigarettes pack-yr (if former smokers withdrawn \>1 year)
* Diagnosis COPD (GOLD criteria1 for more than a year before V0)
* Presence of chronic bronchitis (cough and/or expectoration for more that 3 months/yr for more than 2 consecutive yrs. in the absence of other potential cause)
* Post-bronchodilator FEV1\<70% reference
* Presence of established CVD, CVD equivalent or diabetes mellitus
* Presence of chronic systemic inflammation, determined on:
1. Serum CRP ≥ 2 and \< 10 mg/l or
2. Serum fibrinogen \> 518 mg/dl and Leucocytes \> 8,6\*106 /mm3
Exclusion Criteria:
* Episode of COPD exacerbation and/or COPD treatment change during the last 2 months before V0
* History of asthma, significant residual lung lesions or bronchiectasis on chest x-ray
* Apnea-hypopnea syndrome
* Poorly controlled CVD risk factors (Table 2) and/or change in their treatment during the last 3 months before V0
* Clinically significant cardiac arrhythmias or valve disease
* Severe concomitant immunological, inflammatory, infectious or neoplastic diseases
* Moderate or severe hepatic insufficiency (B or C class, following Child-Pugh scale)
* Severe neurologic and/or psychiatric disorder, including depression with suicidal ideas
* Alcohol and/or drug abuse during the last 12 months before V0
* Hypersensitivity to roflumilast or to any of its excipients
* Pregnancy or potential pregnancy
* Participation in other clinical trial during the last 30 days before V0
* Language difficulties to follow the instructions of the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
75 Years
Study:
NCT01595750
Study Brief:
Protocol Section:
NCT01595750